Search > Open-Angle Glaucoma

CycloPen System for Open-Angle Glaucoma

(CREST Trial)

Enrolling by invitation at 17 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Iantrek, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the CycloPen Cyclodialysis System, a micro-interventional device, for individuals with open-angle glaucoma, a common eye condition that can lead to vision loss. It tracks changes in eye pressure and medication use after surgery with this system. The trial includes two groups: one undergoing the CycloPen procedure with cataract surgery and another undergoing only the CycloPen procedure. It targets those who have already had surgery to lower eye pressure. Researchers will observe participants for two years to monitor their progress over time. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment option.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. It seems to focus on observing patients who have already had surgery, so you might be able to continue your usual medications.

What prior data suggests that the CycloPen Cyclodialysis System is safe for reducing intraocular pressure in adults with open angle glaucoma?

Research has shown that the CycloPen Cyclodialysis System, whether used with cataract surgery or alone, is generally well-tolerated. Previous studies reported a low rate of complications, with no serious eye-related problems. This suggests the procedure is safe for most patients. Additionally, it has a good safety record, rarely causing harmful side effects. These findings are encouraging for those considering participation in a clinical trial for this treatment.12345

Why are researchers excited about this trial?

Researchers are excited about the CycloPen Cyclodialysis System because it offers a novel approach to treating eye conditions like glaucoma, especially in conjunction with cataract surgery. Unlike traditional treatments that often rely on medication or invasive surgery to reduce intraocular pressure, the CycloPen system uses a micro-interventional technique. This technique allows for precise adjustment of fluid drainage from the eye, potentially offering more controlled and effective pressure relief. Additionally, it can be integrated seamlessly with cataract surgery, providing a dual benefit for patients undergoing eye procedures. This innovative approach has the potential to improve long-term outcomes for patients with glaucoma, making it a promising development in ophthalmic care.

What evidence suggests that the CycloPen Cyclodialysis System is effective for open angle glaucoma?

This trial will evaluate the CycloPen Cyclodialysis System in two different surgical contexts. Research has shown that the CycloPen Cyclodialysis System, when used during cataract surgery, holds promise for treating open angle glaucoma (OAG). One study found it lowered eye pressure by 34% in most patients, while others achieved an average eye pressure of 12.62 with minimal medication. This combination also proved safe and effective over the long term.

In standalone surgeries using only the CycloPen System, more than 200 cases reported successful results. Patients experienced a significant drop in eye pressure and required fewer medications. The procedure generally involved few complications, indicating it is a safe and effective treatment for OAG.16789

Who Is on the Research Team?

TI

Tsontcho Ianchulev, MD

Principal Investigator

Iantrek, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

You have an intraocular pressure of less than 31 mmHg prior to surgery.
You have used ≤ 3 ocular hypotensive medications prior to surgery.
You have undergone an IOP-lowering surgical procedure using the CycloPen System.

Exclusion Criteria

You have a narrow angle in your eye.
Clinically significant corneal abnormality or concurrent intraocular pathology
Previous trabeculectomy or tube-shunt surgery, or previous iridotomy
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Data collected from preoperative visit(s) directly preceding surgery

1-2 weeks

Surgery

Ophthalmic surgical intervention with the CycloPen Cyclodialysis System

Postoperative Follow-up

Participants are monitored for safety and effectiveness, including IOP and medication use

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • CycloPen Cyclodialysis System

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: CycloPen Cyclodialysis System in standalone surgeryExperimental Treatment1 Intervention
Group II: CycloPen Cyclodialysis System in conjunction with cataract surgeryExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Iantrek, Inc.

Lead Sponsor

Trials
2
Recruited
500+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11354769/

Surgical Outcomes, Ocular Safety and Tolerability of Bio ...

We report the surgical outcomes of more than 200 cases of scleral allograft implantation for intraocular ab-interno endoscleral reinforcement.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05506423

NCT05506423 | Study of the CycloPen Micro-Interventional ...

Specific data to be collected includes details of the CycloPen surgical procedure, IOP, use of ocular hypotensive medications, and any side effects related to ...

3.

ophthalmologyscience.org

ophthalmologyscience.org/article/S2666-9145(25)00025-9/fulltext

2-Year Results of Cyclodialysis with Scleral Allograft ...

The primary outcome was the proportion of eyes achieving ≥20% intraocular pressure (IOP) reduction with same or fewer medications compared with baseline.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11629670/

Bio-Interventional Cyclodialysis and Allograft Scleral ...

Successful cyclodialysis and allograft bio-scaffold reinforcement was achieved in 117 eyes. There was minimal intraoperatie bleeding and few ...

5.

glance.eyesoneyecare.com

glance.eyesoneyecare.com/stories/2024-09-12/new-research-investigates-uveoscleral-outflow-technology-for-oag/

New research investigates uveoscleral outflow technology ...

Real-world clinical evidence study evaluates IOP reduction following use of Iantrek's CycloPen System during cataract surgery.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05506423

NCT05506423 | Study of the CycloPen Micro-Interventional ...

Data regarding IOP, use of glaucoma medications, and any side effects related to the surgery will be collected from participants' preoperative examination, ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666914525000259

Bio-interventional Uveoscleral Outflow Enhancement ...

Objective. To evaluate safety and efficacy of the scleral allograft–reinforced cyclodialysis through 24 months of follow-up. Design. Interventional ...

8.

ophthalmologyscience.org

ophthalmologyscience.org/article/S2666-9145(25)00025-9/pdf

2-year results of cyclodialysis with

The procedure was well tolerated and there were no serious ocular adverse events. 53. 54. Conclusion: Uveoscleral outflow enhancement can be ...

9.

pdfs.semanticscholar.org

pdfs.semanticscholar.org/68e6/ef3c965867fdcfd0e9d27faf1a609bbbcec9.pdf

Surgical Outcomes, Ocular Safety and Tolerability of Bio- ...

Abstract: Background: To report the surgical safety of reinforced bio-interventional cyclodialysis with scleral allograft reinforcement.

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